MSD QA Associate Director 

Ireland, Dublin 

55514685

Job Description

An exciting opportunity has arisen for aQuality Assurance Associate Director

The role ensures that the QA team objectives are effectively achieved, consistent with the company’s requirements to ensure compliance, safety, and reliable supply to our customers. This leadership position will report directly to the Quality Assurance Operations Director for Biotech Dublin. This is key position that will navigate and direct the team through sustaining business priorities, projects, and new production introduction as required. This role will suit a current leader who wishes to broaden their Operations expertise or someone with a technical background who wishes to further develop their leadership skills.

Bring energy, knowledge, innovation, and leadership to carry out the following:

• Provide leadership to the QA Operations team (Upstream and/or Downstream) for project driven priorities, new product introduction and sustaining business activities.
• Responsible for ensuring that the processes for the manufacture of biologics have been conducted in compliance with GMP, the registered marketing authorisation and the associated regulatory requirements.
• In-depth knowledge of US and European GMP guidelines, ICH, and other international regulatory requirements, as applicable to the site.
• Creates a diverse and inclusive culture that excels in safety, quality and delivers on the strategic vision for Biotech Dublin QA Operations.
• Lead, coach, and mentor the QA Operations team. Build diverse talent with the capabilities necessary to succeed in commercial drug substance manufacture Develop team members through supporting their continued personal and professional career growth.
• Provides coaching and guidance to new personnel and to Quality Specialists and Sr. Quality Specialists, respectively.
• Inspire Diversity and Inclusion by building effective working relationship with cross-functional teams across diverse cultures and backgrounds.
• Proactively partner with IPT Operations Leads with respect to, real time on the floor support, batch record review and right first time.
• Maintains strong quality management systems oversight to actively ensure compliance while striving to optimize Quality Operations with the IPT (Integrated Process Team).
• Support various site functional and cross functional tier structures.
• Responsible for the Quality oversight and classification/approval of investigative events and deviations. Provides guidance to Senior Quality Specialists conducting reviews/approvals of investigative events.
• Assisting in and facilitating investigations (leading where required), ensuring effective Root Cause Analysis and CAPAs are identified and implemented.
• Completes review and approval for CAPAs, change requests, and investigative protocols and final reports.
• Actively participate in the Tier process, as appropriate, and uses this forum to escalate concerns and best practices.
• Inspire Diversity and Inclusion – building effective working relationship within a cross-functional team across diverse cultures and backgrounds.
• Stakeholder management of multiple decision makers, corporate colleagues, cross-functional team by demonstrating the ability to maintain and strengthen trust relationships with people on all levels.
• Drive and own metrics that appropriately and accurately measure QA Operations performance and take action to mitigate as required.
• Be an advocate for continuous improvement, modern technologies, and innovation. Lead and foster an environment of continuous improvement through problem solving and leader’s standard work.
• Actively participate in Site/Quality committees and works with other site functional groups to help set direction for GMP and continuous improvement initiatives.
• Represent the QA department during Regulatory Inspections and other internal GMP inspections.

What skills you will need:

• Degree (or higher) in Chemistry, Biology, Microbiology, Science, Engineering or in a relevant discipline, the successful candidate will also have significant exposure in delivering operational excellence in GMP environment.
• This role requires a seasoned professional with the expertise (10 to 15 years) with at least 5 years in a leading position and attributes that will ensure success in this highly accountable role.
• Working knowledge in the biotech industry is required with specific understanding of QA operations an advantage, regulatory agency engagement and ability to gain alignment on strategy.
• The successful candidate should have the knowledge and ability to mentor the QA systems implemented at the site.
• Strong stakeholder management skills and proven experience dealing with above site groups, particularly for divisional systems.
• Demonstrated ability to manage multiple priorities against ambitious timelines.
• Strong problem-solving skills and ability to work cross-functionally as critical member of site team.
• Hands-on application of lean tools and techniques: standardized work, scientific problem solving, value stream mapping, capacity analysis.
• Coaching, teaching, and driving a High-Performance Organization. Proven experience in coaching and teaching others to think, behave and apply lean methods and tools and active problem-solving mindset. Experience enabling and leveraging diverse perspectives, talents, etc. to achieve business outcomes.

General competencies:

• Leadership experience in one or all (desired) functional groups; Quality Systems, Quality Assurance, Operations in Vaccine or Biological Operations.
• A self-starter and results-focused, the successful candidate will have strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.
• Strong collaboration and cross-functional leadership skills to drive continuous improvement and promote knowledge sharing and implementation of best practices across the site and Compliance functions on global and local level.
• Proven ability to effectively initiate and drive change across the site.
• Strong verbal and written communication skills, project management skills.
• Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives.
• Ability to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights.

Technical:

• Manufacturing experience in Biological Operations.
• Experience with new product introductions and technology transfer (optional)

People:

• The successful candidate should have the knowledge, and style to mentor the site through the planning, strategy build and execution.
• Confidence and Leadership style to successfully develop strategy and implement.
• The motivation to be an inspiring member of a high performing team.
• Build upon the strong Speak Up Culture at Biotech Dublin.
• A great communicator, decisive decision maker and proven ability to deliver excellence.
• Willingness to support coach the teams

So, if you are ready to:

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.